Tag: DOT

DOT Proposes New Guidance For Medical Examiners To Address CBD Use By Commercial Motor Vehicle Drivers

The U.S. Department of Transportation, Federal Motor Carrier Safety Administration (FMCSA) published a proposed draft Medical Examiner’s Handbook (MEH), including updates to the Medical Advisory Criteria, in the Federal Register on August 16, 2022.  The FMCSA’s regulations provide the basic driver physical qualification standards for commercial motor vehicle (CMV) drivers, in 49 CFR 391.41 through 391.49. DOT Medical Examiners currently make physical qualification determinations on a case-by-case basis and may consider guidance to assist with making those determinations.

FMCSA stated that the goal of the updated MEH and related Medical Advisory Criteria is to provide information about regulatory requirements and guidance for Medical Examiners to consider when making physical qualification determinations in conjunction with established best medical practices. The revised Medical Advisory Criteria, in addition to being included in the MEH, would also be published in Appendix A to 49 CFR part 391. The final version of the criteria would be identical in both publications. FMCSA is proposing to update both the MEH and Medical Advisory Criteria and seeks public comment on these documents until September 30, 2022.  The draft MEH may be viewed here.

Use of CBD with 0.3% THC or Less Is Not Automatically Disqualifying

Under FMCSA regulation 49 CFR 391.41(b)(12)(i), CMV drivers are not permitted to be physically qualified when using Schedule I drugs under any circumstances. The federal Controlled Substances Act lists marijuana, including marijuana extracts containing greater than 0.3% delta-9-tetrahydrocannabinol (THC), as Schedule I drugs and substances. A driver who uses marijuana cannot be physically qualified even if marijuana is legal in the State where the driver resides for recreational or medical use.

However, under current federal law cannabidiol (CBD) products containing less than 0.3% THC are not considered Schedule I substances; therefore, their use by a CMV driver is not grounds to automatically preclude physical qualification of the driver under §391.41(b)(12)(i).

FMCSA emphasized that the U.S. Food and Drug Administration (FDA) does not currently determine or certify the levels of THC in products that contain CBD, so there is no federal oversight to ensure that the labels on CBD products that claim to contain less than 0.3% of THC are accurate. Therefore, drivers who use these products are doing so at their own risk.

FMCSA now proposes that each driver should be evaluated on a case-by-case basis and encourages Medical Examiners to take a comprehensive approach to medical certification and to consider any additional relevant health information or evaluations that may objectively support the medical certification decision. Medical Examiners may request that drivers obtain and provide the results of a non-DOT drug test during the medical certification process, if it is deemed to be helpful in determining whether a driver is using a prohibited substance, such as a CBD product that contains more than 0.3% THC.

This guidance does not impact FMCSA’s drug and alcohol testing regulations.  Use of a CBD product does not excuse a positive marijuana drug test result.

Use of Suboxone and Similar Drugs Is Not Automatically Disqualifying

FMCSA received a large number of inquiries related to Suboxone (a Schedule III drug under federal law, meaning that it has a lower potential for abuse than Schedule I and II drugs).  Treatment with Suboxone and other drugs that contain buprenorphine and naloxone, as well as methadone, are not identified in the FMCSA regulations as precluding medical certification for operating a CMV. FMCSA relies on the Medical Examiner to evaluate and determine whether a driver treated with Suboxone singularly or in combination with other medications should be issued a medical certificate. The Medical Examiner should obtain the opinion of the prescribing licensed medical practitioner who is familiar with the driver’s health history as to whether treatment with Suboxone will or will not adversely affect the driver’s ability to safely operate a CMV. The final medical certification determination, however, rests with the Medical Examiner who is familiar with the duties, responsibilities, and physical and mental demands of CMV driving and non-driving tasks.

Article By Kathryn J. Russo of Jackson Lewis P.C.

For more biotech, food, and drug legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2022

DOT Issues Notice of Enforcement Discretion Regarding the Transportation of Hand Sanitizers to Address COVID-19

On April 2, 2020, the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a Notice of Enforcement Discretion (Notice) that provides temporary relief from certain aspects of the DOT Hazardous Materials Regulations (HMR) that normally apply to the transportation of ethyl alcohol or isopropyl alcohol-based hand sanitizers. [1]

Due to the Coronavirus Disease 2019 (COVID-19) public health emergency, demand for hand sanitizer has reached unprecedented levels. Many of these sanitizers are classified as Class 3 flammable liquids due to the alcohol content, which would trigger certain marking, labeling, packaging, documentation, and other compliance obligations for shippers (and carriers) under the DOT HMR. Although the DOT HMR already provide some regulatory relief for certain ethyl alcohol products in 49 CFR 173.150(g), this does not cover isopropyl alcohol products and it does not cover ethyl alcohol products in larger containers. To facilitate the availability of these products, PHMSA is providing temporary relief from certain HMR requirements.

The Notice indicates that the relief applies to companies producing hand sanitizer under a recently issued Food and Drug Administration (FDA) Guidance document and to those who subsequently transport the hand sanitizer. [2]

Importantly, it applies only to highway shipments (by private, common, or contract carriers by motor vehicle) and not shipments by air, vessel, or rail.

If parties follow the procedures for preparing hand sanitizer for shipment set forth in the Notice (as compared to all of the requirements specified in the HMR), PHMSA will not take enforcement action for violations of the HMR. The Notice provides separate procedures for shipping small quantities (< 1 gallon/container or 8 gallons/package) and for larger quantities (> 8 gallons to 119 gallons/package) of hand sanitizer.

© 2020 Keller and Heckman LLP

For more on manufacture & transportation of emergency medical supplies for the COVID-19 pandemic, see the National Law Review Coronavirus News section.

PHMSA Raises Random Drug Testing Rate to 50% for 2018

The U.S. Department of Transportation’s Pipeline and Hazardous Materials Safety Administration announced December 8, 2017 that during calendar year 2018, the minimum random drug testing rate will be increased to 50%.

Operators of gas, hazardous liquid, and carbon dioxide pipelines and operators of liquefied natural gas facilities must randomly select and test a percentage of all covered employees for prohibited drug use. The minimum annual random drug testing rate was 25% of all covered employees for calendar year 2017.  However, the PHMSA regulations require the Administrator to raise the minimum annual random drug testing rate from 25% to 50% of all covered employees when the data obtained from the Management Information System reports (required to be filed by covered entities under PHMSA regulations) indicate the positive test rate is equal to or greater than 1%.  In calendar year 2016, the random drug test positive test rate was greater than 1%.  Therefore, the PHMSA minimum annual random drug testing rate shall be 50% of all covered employees for calendar year 2018.

Jackson Lewis P.C. © 2017
This post was written by Kathryn J. Russo of Jackson Lewis P.C.
Check out the National Law Review Labor and Employment page for more information.

Obama Administration DOT to Continue Issuing Regulations; Potential DOT Secretaries in Trump Administration

Obama Administration DOTObama Administration DOT to Continue Issuing Regulations

The Obama Administration’s Department of Transportation (DOT) is expected to continue issuing regulations until President-Elect Donald Trump takes office in January. Over the final two months of the Administration, DOT is expected to issue regulations banning cellphone calls on flights and requiring freight trains to use two crew members. Additionally, DOT is expected to issue guidance on vehicle-to-infrastructure technologies, a proposed rule on vehicle-to-vehicle communications, and a proposed rule on operating unmanned aircraft systems (drones) over crowds.

While President-Elect Trump has indicated he will immediately begin undoing regulations and reversing President Obama’s executive actions, it is unclear whether the incoming Trump Administration will prioritize looking at DOT regulations and transportation-related executive actions.

Potential DOT Secretaries in a Trump Administration

The President-Elect Donald Trump’s transition team is currently evaluating potential picks for DOT Secretary. Individuals that have been discussed as candidates include: Representative John Mica (R-FL), a current member of the House Transportation and Infrastructure Committee who lost his reelection campaign this year; James Simpson, a former commissioner of New Jersey’s Department of Transportation and a former head of the Federal Transit Administration; and Mark Rosenker, a former National Transportation Safety Board Chairman; Greg Hughes, the speaker for Utah’s house of representatives; and former Representative Harold Ford Jr. (D-TN), a potential democratic cabinet pick.

This Week’s Hearings:

  • On Friday, December 2, the House Oversight and Government Reform Subcommittee on Transportation and Public Assets will hold a hearing titled “A Safe Track?: Oversight of WMATA’s Safety and Maintenance.” The witnesses will be announced.

ARTICLE BY Timothy W. Drake of Squire Patton Boggs (US) LLP

© Copyright 2016 Squire Patton Boggs (US) LLP

OSHA Enforcement Directive on HazCom Compliance a Mixed Blessing

A new directive from the Occupational Safety and Health Administration on enforcing the agency’s Hazard Communication (HazCom) standard describes requirements that appear to impose new, unforeseen paperwork and compliance burdens on employers even while providing useful clarifications on some issues for employers and enforcement personnel. The “Inspection Procedures for the Hazard Communication Standard (HCS 2012)” was released July 20, 2015, and explains how the standard is to be enforced during the current transition period and after the standard is fully implemented. OSHA’s HazCom rule was amended in 2012 to align U.S. HazCom mandates with a globally harmonized system of classifying and labeling hazardous chemicals.osha-logo

Observers identified at least three areas of concern about the new policy. They involve requirements for documentation of good-faith compliance efforts, written HazCom program instructions, and procedures for classifying chemicals. Critics believe they could lead to added costs, including from citations.

According to the directive, inspectors are to determine if all applicable provisions of paragraphs (e) through (h) of the standard have been covered in the written program and implemented in the workplace. These provisions include the chemical inventory, which must show a product identifier for each chemical known to be present that aligns with the Safety Data Sheet (SDS) and label. The inventory is to include chemicals present in storage or otherwise not in use.

In addition, the written program must designate the person(s) responsible for obtaining or maintaining SDSs, how the data sheets are to be maintained, procedures on how to retrieve SDSs electronically, including backup systems to be used in the event of failure of the electronic equipment, and how employees obtain access to SDSs. Also required are procedures addressing what to do if an SDS is not received at the time of the first shipment, if there is reason to believe the SDS is not appropriate (e.g., missing hazards), to determine if the SDS is current, and, for chemical manufacturers or importers, for updating the SDS when new and significant health information is found. In addition to the written program, there are detailed requirements for labeling, training, evaluating chemicals, and much more.

OSHA appears to be using the policy to push enforcement priorities at the agency. It is a means of requiring staffing firms that provide temporary employees to train those employees to protect themselves from hazardous chemicals they may encounter at the host employer’s worksite. Inspectors also are given detailed guidance on how to evaluate an SDS for a general duty clause violation in cases where there is potential exposure to a chemical with no permissible exposure limit (“PEL”). Frustrated with its inability to update outdated PELs, OSHA has long-hinted it would use the general duty clause in this way.

“They are clearly encompassing their enforcement initiatives into this directive,” said Jackson Lewis attorney Tressi Cordaro. “The approach not only lacks any legal basis in the standard or in OSHA’s governing statute, but also circumvents the regulatory process. That is rulemaking without notice and comment,” she contended.

Cordaro noted that the directive provides useful clarification on some issues, such as employer reliance on Department of Transportation (DOT) labeling for shipping of hazardous chemicals. “There’s some value in this directive. OSHA gave some clarification to DOT labeling,” she said. “That’s guidance that was needed in the industry.”

Enforcement of the standard is in transition. Employers were required to train workers on the new label elements and safety data sheets by December 1, 2013. Chemical manufacturers, importers and distributors had to comply with revised SDS requirements by June 1, 2015. Manufacturers and importers had to comply with new labeling provisions by June 1, 2015. Distributors have until December 1, 2015, to comply with labeling provisions as long as they are not relabeling materials or creating SDSs, in which case they must comply with the June 1 deadline. Full implementation begins on June 1, 2016.

ARTICLE BY Avi Meyerstein of Jackson Lewis P.C.

Jackson Lewis P.C. © 2015

DOT Proposes Rules for Rail Transport of Flammable Materials: New Standards for Classification, Tank Cars, Emergency Preparedness

Beveridge Diamond Law Firm

Following recent events highlighting the potential devastating effects of accidents involving rail transportation of flammable liquids, the Pipeline and Hazardous Materials Safety Administration (PHMSA) of the U.S. Department of Transportation (DOT) released a pre-publication copy of a Notice of Proposed Rulemaking (NPRM) on July 23 designed to improve the safety of transporting such materials. The proposed regulations come more than a year after the derailment and explosion of a train carrying 72 tank cars, each filled with 30,000 gallons of Bakken crude oil in Lac-Mégantic, Quebec, that killed 47 people. PHMSA will accept comments 60 days from the date of publication (not yet available) in the Federal Register. Given the extensive comments received on the Advanced Notice of Proposed Rule Making (ANPRM), the agency has indicated it does not intend to extend the comment period.

Classification and Characterization Requirements of Mined Liquids and Gases

Under the proposed regulations, all offerors and shippers would be required to implement a sampling and testing program for mined gases and liquids extracted from the earth (e.g., crude oil) to ensure their hazards are understood and accounted for in packaging and emergency preparedness. Offerors would be required to maintain documentation of the sampling and testing program, review their program annually, and make program documentation available to DOT upon request. The program would include:

  • Frequency of sampling to understand material variability;
  • Sampling of different points along the supply chain to understand changes during transportation;
  • Sampling methods that ensure samples representative of entire mixtures, as packaged;
  • Testing methods to ensure better analysis, classification, and characterization of materials;
  • Statistical justifications for sample frequencies;
  • Duplicate samples for quality assurance; and
  • Criteria for modifying sampling and testing programs.

Additional Operational Requirements for High-Hazard Flammable Trains

The proposed regulations would impose additional requirements for high-hazard flammable trains (HHFTs), defined by the NPRM as trains carrying 20 or more tank carloads of a Class 3 flammable liquid. Specifically, all HHFT units constructed after October 1, 2015 must comply with DOT-117 tank car design requirements for tank cars, such as inclusion of thermal protection systems and tank car plate thickness requirements. The rule would phase out DOT-111 tank cars, the oldest tank cars in use, on the following schedule:

HHFT Class 3 Flammable Liquid Packing Group DOT-111 Not Authorized After
I October 1, 2017
II October 1, 2018
III October 1, 2020

Along with changes to tank car design specifications, operators of HHFTs would have to implement the following requirements:

  • Use of Risk Assessment in Route Selection: The proposed rule would apply rail routing requirements currently required of trains carrying certain volumes of Toxic-by-Inhalation (TIH) Chemicals, and other highly hazardous materials to HHFTs. Carriers would be required to apply 27 safety and security factors, including population density along routes, emergency response capability along the route, among others, in selecting a route for HHFTs.
  • Notification to SERCs: The rule would make permanent a May 2014 DOT emergency order requiring HHFTs carrying more than one million gallons of Bakken crude oil to notify State Emergency Response Commissions (SERCs) and other appropriate state officials about the operation of such trains through their states. Carriers would be required to report such information within 30 days of the effective date of the rule and to maintain documentation of notifications that could be made available to the Federal Railroad Administration (FRA) upon request.
  • Speed Limits and Enhanced Braking Requirements: HHFTs would be limited to 50 mph in all areas. PHMSA seeks comments on whether HHFTs that do not meet design specifications should be subject to 40 mph speed limit options in certain areas. The proposed regulations also would require HHFTs to be equipped with alternative brake propagation systems as an added safety precaution.

Other DOT Actions

Along with the NPRM, DOT issued a companion ANPRM seeking comment on the application of oil spill response planning to the shipment of flammable liquids as well as an Operation Safe Delivery Update report containing data collected from its staff and the FRA from August 2013 to May 2014. This report concludes that Bakken crude oil is more volatile and flammable compared to other crude oils. In a press release, DOT claims that it will continue to monitor the data through the fall of 2014.

ARTICLE BY

Elizabeth M. Richardson
Fred R. Wagner
Gayatri M. Patel
Of:
Beveridge & Diamond PC